Factors (e.g., coronary sinus obstructions, absence of a suitable cardiac vein, high thresholds, or pheric nerve stimulation) warrant the need for an alternative to a transvenous approach to the implantation of left ventricle (“LV”) leads in congestive heart failure (“CHF”) patients in need of cardiac rhythm treatment (“CRT”). Historically, the alternative to a transvenous approach has entailed placement of an epicardial lead, which required invasive surgery and an associated hospital stay.
A minimally invasive pericardial approach to implanting a stimulating lead (e.g., a LV lead) has shown great promise as an alternative to the aforementioned transvenous and invasive surgery methods. In the pericardial approach, an introducer sheath is used to deliver a lead via a subxiphoid access to an implant location within the pericardial space. Visualization techniques, such as traditional fluoroscopy, MRI or endoscopy, are used to guide the introducer sheath to the implantation location within the pericardial space and to guide the final positioning of the lead. The pericardial approach is advantageous for a number of reasons. First, it does not require access to the vascular system. Second, it is minimally invasive and does not require surgical intervention and the associated general anesthesia. Third, it allows for a pathway to the entire exterior of the heart (e.g., any chamber, blood vessel or other anatomical feature of the heart) via a single entry point in the patient and in the pericardial sac. As a result, the minimally invasive pericardial approach offers greater simplicity and safety as compared to the transvenous and surgical approaches to stimulation lead implantation.
Despite the great promise shown by the minimally invasive pericardial approach, a current challenge continues to be an inability to reliably achieve a mechanically and electrically stable fixation of a stimulation lead at a preferred implantation site within the pericardial space. Consequently, there is a need in the art for a device and method that addresses the fixation challenge.